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There has been much debate over whether the FDA drug approval process is adequate and whether the surge in drug recalls over the last several years is due to a lack of oversight. Arguments on both side of the issue debate whether the process properly protects the rights of consumers or whether it stifles the ability of drug makers to continue developing more effective treatments and alternatives for those who may not respond well to the medications currently on the market. Let’s take a look at the FDA’s approval process for new medications.

Development of a New Medication is a Long and Expensive Process

It can take over a decade and upwards of $350 million for a new medication to make it through the approval process and the FDA attempts to balance innovation with the need to protect patients. Well before a medication is even submitted for approval, a pharmaceutical company will have performed its own internal research to determine whether it is worth moving it into the approval stage. Even though we have seen a rise in the number of drugs making it to market each year, it is worth noting that only one in every one thousand potential medications that make it into a lab are pursued as viable medications.

Once a drug manufacturer has created a medication that it wishes to move to market, there is a three step process that the medication must move through before it receives approval. These phases all involve clinical trials and the sample groups get larger as the medication continues to move through the steps. Here they are.

Phase One— a small group of under 80 participants are provided the medication to determine whether it is safe and if the patients experience any notable side effects. There is a control group that the patients are compared to in order to ensure the accuracy of the experiment. The volunteers in this study are healthy, as opposed to patients who suffer from the condition that the medication is attempting to remedy. The reason for this is that the primary purpose of this phase is to determine whether the medicine is safe rather than effective. It will take about a year for a drug to pass through this phase.

Phase Two— a sample of 100 to 300 patients is selected to receive the medication to determine whether the medication is effective at treating the condition. Further research is performed to study side effects and potential risks, but the primary focus remains on whether the medication actually treats the condition it is intended for. It takes about two years to move through this phase.

Phase Three— between 1,000 and 3,000 patients in medical facilities are administered the medication under close supervision to record how effective the treatment is and whether there are any notable reactions that could pose a risk. It takes three years to complete this phase.

The goal is to allow pharmaceutical companies to continue innovating, but there is also worthy reason for the public to distrust the willingness of drug companies to play fair. On countless occasions, it has been discovered that a pharmaceutical company deliberately withheld information from the FDA and the public when knowing of potential risks.

The fair solution would be to allow patients to decide whether the risks are worth the benefit of a medication, but when side effects become potential sales deterrents, drug makers use dirty tactics to encourage the use of medications that are not as safe as advertised. A surge in the number of recalls in recent history reaffirms the need for a longer and more stringent approval process rather than relaxing the requirements.

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The Drug Law Center is sponsored by lawyers who represent individuals and families who have suffered a serious injury or death from a dangerous drug or medical device. While these medical inventions have been marketed to improve the quality of life for people, unsafe drugs and poorly designed medical devices can drastically reduce the quality of life for the individual and his or her family.